U.S. Won't Pursue Case of Drug Representative and 'Off-Label' Promotion

Jan. 25--The federal government has decided not to ask the U.S.
Supreme Court to overrule a recent appeals court decision that
overturned the conviction of a pharmaceutical sales representative
who claimed his First Amendment rights were infringed by
prosecutors seeking to enforce Food and Drug Administration limits
on drug promotion.

Working a territory on Long Island, Alfred Caronia sold Xyrem, a
drug approved for narcolepsy, for Orphan Medical Inc., now known as
Jazz Pharmaceuticals, which has its main office in Philadelphia and
a facility in Langhorne.

A jury found Caronia guilty of conspiracy to introduce a
misbranded drug into interstate commerce. Doctors can prescribe any
drug approved by the FDA, but drug companies cannot promote a drug
for an illness not approved by the FDA and on the official label.
Such promotion is considered "off-label."

Caronia argued that violated his right to free speech.

Though drug companies would like to have Caronia’s victory
extended nationwide, lawyers following the case said that would not
happen, at least for now, because the decision was limited to New
York, Connecticut, and Vermont, the area covered by the U.S. Court
of Appeals for the Second Circuit.

Former federal prosecutor Virginia Gibson, a partner at Hogan
Lovells in Philadelphia, said in December that the Second Circuit
decision "does not change the safety regime that the FDA runs to
protect patients."

"It may prompt the FDA to issue more guidance on a number of
topics," she said.

In a statement, the agency said, "FDA does not believe that the
Caronia decision will significantly affect the agency’s
enforcement of the drug-misbranding provisions of the Food, Drug
and Cosmetic Act. The decision does not strike down any provision
of the . . . act or its implementing regulations, nor does it find
a conflict between the act’s misbranding provisions and the
First Amendment or call into question the validity of the
act’s drug approval framework."

--

Contact David Sell at 215-854-4506, dsell@phillynews.com or
follow on Twitter @phillypharma. Read his blog at
www.philly.com/phillypharma.